Clinical Outcomes and Host Immune Response in Vascular Graft and Endograft Infections

Analysis of Clinical Outcomes and Host Immune Response to Vascular Graft and Endograft Infections

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07696884

Acronym

ACHIEVE

Enrollment

300

Registered

2026-07-10

Start date

2024-05-17

Completion date

2033-09-01

Last updated

2026-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Graft Infection, Vascular Endograft Infection, Vascular Graft Infection

Keywords

VGEI

Brief summary

ACHIEVE is a prospective observational cohort and biobank study of patients with suspected or diagnosed central vascular graft or endograft infection. The study also includes patients undergoing elective central vascular graft or endograft implantation and healthy blood donor controls. Participants undergo longitudinal clinical data collection and biospecimen sampling. The study aims to characterize clinical outcomes, host immune responses, inflammatory biomarkers, pathogen-related factors, and novel microbiological diagnostic methods, including microbial cell-free DNA sequencing, in vascular graft and endograft infections.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Age 18 years or older. * Able and willing to provide informed consent. * For the vascular graft or endograft infection group: suspected or diagnosed vascular graft or endograft infection in a central vascular prosthesis as determined by the treating clinicians. * For the elective vascular graft or endograft control group: planned central vascular graft or endograft implantation. * For the healthy blood donor control group: active blood donor registered at Aarhus University Hospital Blood Bank. * For the healthy blood donor control group: no current infection or other active disease.

Exclusion criteria

* For the elective vascular graft or endograft control group: surgery performed as an emergency procedure within 24 hours. * For the elective vascular graft or endograft control group: reoperation of a previously implanted vascular graft or endograft. * For the elective vascular graft or endograft control group: evidence suggestive of ongoing infection in the area of surgery. * Unable to provide informed consent.

Design outcomes

Primary

Measure	Time frame	Description
Percentage of peripheral blood myeloid-derived suppressor cells among live PBMCs at baseline	At baseline/inclusion	Percentage of live PBMCs identified as myeloid-derived suppressor cells by flow cytometry, compared between participants with vascular graft or endograft infection and elective vascular graft/endograft controls.
Proportion of selected VGEI sampling events with clinically adjudicated mNGS positivity	At each paired VGEI sampling event from inclusion through follow-up, up to 10 years	Selected VGEI sampling events with final consensus sample-level mNGS result classified as positive divided by all selected VGEI sampling events within the predefined clinical sampling category.
Proportion of selected VGEI sampling events with clinically relevant paired blood culture positivity	At each paired VGEI sampling event from inclusion through follow-up, up to 10 years	Selected VGEI sampling events with clinically relevant positive paired blood culture divided by all selected VGEI sampling events within the predefined clinical sampling category.

Secondary

Measure	Time frame	Description
Proportion of selected VGEI sampling events with additional clinically relevant mNGS yield	At each paired VGEI sampling event from inclusion through follow-up, up to 10 years	Selected VGEI sampling events with consensus sample-level mNGS positivity and negative paired blood culture divided by all selected VGEI sampling events within the predefined clinical sampling category.

Countries

Denmark

Contacts

CONTACTRasmus A Nielsen, MD

raalni@rm.dk+4522897999

Outcome results